The following data is part of a premarket notification filed by 11 Health Technologies Limited with the FDA for Smartbag (smartpouch).
| Device ID | K181643 |
| 510k Number | K181643 |
| Device Name: | SmartBag (SmartPouch) |
| Classification | Collector, Ostomy |
| Applicant | 11 Health Technologies Limited The Kinetic Business Centre, Theobald Street Borehamwood, GB Wd6 4pj |
| Contact | Michael Seres |
| Correspondent | Priya Woodun 11 Health Technologies Limited The Kinetic Business Centre, Theobald Street Borehamwood, GB Wd6 4pj |
| Product Code | EXB |
| Subsequent Product Code | EZQ |
| Subsequent Product Code | EZS |
| Subsequent Product Code | LHQ |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-22 |
| Decision Date | 2018-11-16 |
| Summary: | summary |